MES 9000 Musculoskeletal System

GUDID D792N91500

Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis.

MYOTRONICS NOROMED, INC

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Primary Device IDD792N91500
NIH Device Record Key883bae0f-d596-417d-9dd1-e4dd109901d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMES 9000 Musculoskeletal System
Version Model NumberN9000M
Company DUNS053824652
Company NameMYOTRONICS NOROMED, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD792N9000M0 [Primary]
HIBCCD792N91500 [Package]
Contains: D792N9000M0
Package: With Static EMG [1 Units]
In Commercial Distribution
HIBCCD792N92000 [Package]
Contains: D792N9000M0
Package: With Dynamic EMG [1 Units]
In Commercial Distribution
HIBCCD792N9200S0 [Package]
Contains: D792N9000M0
Package: With Dynamic EMG [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZMDevice, Muscle Monitoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

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